Focused compression mitral valve device and method

ABSTRACT

A mitral valve therapy device and method treats dilated cardiomyopathy. The device is configured to be placed in the coronary sinus of a heart adjacent to the mitral valve annulus. The device includes a force distributor that distributes an applied force along a pericardial wall of the coronary sinus, and a force applier that applies the applied force to one or more discrete portions of a wall of the coronary sinus adjacent to the mitral valve annulus to reshape the mitral valve annulus in a localized manner.

FIELD OF THE INVENTION

[0001] The present invention generally relates to a device and methodfor treating dilated cardiomyopathy of a heart. The present inventionmore particularly relates to a device and method for delivering alocalized force to the mitral valve annulus to reshape the mitral valveannulus.

BACKGROUND OF THE INVENTION

[0002] The human heart generally includes four valves. Of these valves,a most critical one is known as the mitral valve. The mitral valve islocated in the left atrial ventricular opening between the left atriumand left ventricle. The mitral valve is intended to preventregurgitation of blood from the left ventricle into the left atrium-whenthe left ventricle contracts. In preventing blood regurgitation themitral valve must be able to withstand considerable back pressure as theleft ventricle contracts.

[0003] The valve cusps of the mitral valve are anchored to muscular wallof the heart by delicate but strong fibrous cords in order to supportthe cusps during left ventricular contraction. In a healthy mitralvalve, the geometry of the mitral valve ensures that the cusps overlieeach other to preclude regurgitation of the blood during leftventricular contraction.

[0004] The normal functioning of the mitral valve in preventingregurgitation can be impaired by dilated cardiomyopathy caused bydisease or certain natural defects. For example, certain diseases maycause dilation of the mitral valve annulus. This can result indeformation of the mitral valve geometry to cause ineffective closure ofthe mitral valve during left ventricular contraction. Such ineffectiveclosure results in leakage through the mitral valve and regurgitation.Diseases such as bacterial inflammations of the heart or heart failurecan cause the aforementioned distortion or dilation of the mitral valveannulus. Needless to say, mitral valve regurgitation must not gouncorrected.

[0005] One method of repairing a mitral valve having impaired functionis to completely replace the valve. This method has been found to beparticularly suitable for replacing a mitral valve when one of the cuspshas been severely damaged or deformed. While the replacement of theentire valve eliminates the immediate problem associated with a dilatedmitral valve annulus, presently available prosthetic heart valves do notpossess the same durability as natural heart valves.

[0006] Various other surgical procedures have been developed to correctthe deformation of the mitral valve annulus and thus retain the intactnatural heart valve function. These surgical techniques involverepairing the shape of the dilated or deformed valve annulus. Suchtechniques, generally known as annuloplasty, require surgicallyrestricting the valve annulus to minimize dilation. Here, a prosthesisis typically sutured about the base of the valve leaflets to reshape thevalve annulus and restrict the movement of the valve annulus during theopening and closing of the mitral valve.

[0007] Many different types of prostheses have been developed for use insuch surgery. In general, prostheses are annular or partially annularshaped members which fit about the base of the valve annulus. Theannular or partially annular shaped members may be formed from a rigidmaterial, such as a metal, or from a flexible material.

[0008] While the prior art methods mentioned above have been able toachieve some success in treating mitral regurgitation, they have notbeen without problems and potential adverse consequences. For example,these procedures require open heart surgery. Such procedures areexpensive, are extremely invasive requiring considerable recovery time,and pose the concomitant mortality risks associated with suchprocedures. Moreover, such open heart procedures are particularlystressful on patients with a comprised cardiac condition. Given thesefactors, such procedures are often reserved as a last resort and henceare employed late in the mitral regurgitation progression. Further, theeffectiveness of such procedures is difficult to assess during theprocedure and may not be known until a much later time. Hence, theability to make adjustments to or changes in the prostheses to obtainoptimum effectiveness is extremely limited. Later corrections, if madeat all, require still another open heart surgery.

[0009] An improved therapy to treat mitral regurgitation withoutresorting to open heart surgery has recently been proposed. This isrendered possible by the realization that the coronary sinus of a heartis near to and at least partially encircles the mitral valve annulus andthen extends into a venous system including the great cardiac vein. Asused herein, the term “coronary sinus” is meant to refer to not only thecoronary sinus itself but in addition, the venous system associated withthe coronary sinus including the great cardiac vein. The therapycontemplates the use of a device introduced into the coronary sinus toreshape and advantageously effect the geometry of the mitral valveannulus.

[0010] The device includes a resilient member having a cross sectionaldimension for being received within the coronary sinus of the heart anda longitudinal dimension having an unstressed arched configuration whenplaced in the coronary sinus. The device partially encircles and exertsan inward pressure on the mitral valve. The inward pressure constrictsthe mitral valve annulus, or at least a portion of it, to essentiallyrestore the mitral valve geometry. This promotes effective valve sealingaction and eliminates mitral regurgitation.

[0011] The device may be implanted in the coronary sinus using onlypercutaneous techniques similar to the techniques used to implantcardiac leads such as pacemaker leads. One proposed system forimplanting the device includes an elongated introducer configured forbeing releasably coupled to the device. The introducer is preferablyflexible to permit it to advance the device into the heart and into thecoronary sinus through the coronary sinus ostium. To promote guidance,an elongated sheath is first advanced into the coronary sinus. Then, thedevice and introducer are moved through a lumen of the sheath until thedevice is in position within the coronary sinus. Because the device isformed of resilient material, it conforms to the curvatures of the lumenas it is advanced through the sheath. The sheath is then partiallyretracted to permit the device to assume its unstressed archedconfiguration. Once the device is properly positioned, the introducer isthen decoupled from the device and retracted through the sheath. Theprocedure is then completed by the retraction of the sheath. As aresult, the device is left within the coronary sinus to exert the inwardpressure on the mitral valve to restore mitral valve geometry.

[0012] The foregoing therapy has many advantages over the traditionalopen heart surgery approach. Since the device, system and method may beemployed in a comparatively noninvasive procedure, mitral valveregurgitation may be treated at an early stage in the mitralregurgitation progression. Further, the device may be placed withrelative ease by any minimally invasive cardiologist. Still further,since the heart remains completely intact throughout the procedure, theeffectiveness of the procedure may be readily determined. Moreover,should adjustments be deemed desirable, such adjustments may be madeduring the procedure and before the patient is sent to recovery.

[0013] Unfortunately, the human anatomy does impose some obstacles tothis recently proposed procedure for treating mitral regurgitation. Morespecifically, the human heart includes a coronary artery which descendsfrom the aorta. One branch of the coronary artery is the circumflexartery which, in turn, includes the left marginal branch of thecircumflex artery. As used herein, the term “circumflex artery” is takento include the circumflex artery itself or any branch therefrom. Thecircumflex artery extends distally generally along the coronary sinusbut at a point proximal to the coronary artery, it passes under thecoronary sinus. The circumflex artery supports blood flow important tothe viability of the heart. Hence, reduction in this blood flow must beavoided. As a result, a device placed in the coronary sinus must not bepermitted to extend within the coronary sinus beyond the crossover pointof the circumflex artery and the coronary sinus in a way which impedesblood flow in the circumflex artery.

[0014] While the foregoing therapy provides many benefits over previoustherapies, the therapy still contemplates the general reshaping of themitral valve annulus. To that end, the devices encircle more than halfof the mitral valve annulus in an attempt to provide generalized mitralvalve annulus reshaping. While this indeed may be successful, it may beunnecessary.

[0015] Recently, it has been observed that the application of alocalized force against a discrete portion of the mitral valve annuluscan terminate mitral regurgitation. This suggests that mitral valvedilation may be localized and nonuniform. Hence, while devices thatattempt to encircle the mitral valve as much as possible for providinggeneralized reshaping of the mitral valve annulus may be effective intreating mitral regurgitation, a localized reshaping therapy may only beneeded. Such localized therapy would have all the benefits of thegeneralized therapy. In addition, a localized therapy device may beeasier to implant and adjust. Further, a localized therapy device maynot require the length of a generalized therapy device, thus providingthe additional advantage of eliminating the need of avoiding thecircumflex artery all together.

SUMMARY OF THE INVENTION

[0016] The invention provides a mitral valve therapy device configuredto be placed in the coronary sinus of a heart adjacent to the mitralvalve annulus. The device includes a force applier that applies anapplied force to a discrete portion of the atrial wall of the coronarysinus adjacent to the mitral valve annulus to concentrate the appliedforce on a discrete portion of the mitral valve annulus.

[0017] The force applier preferably has a cross-sectional dimensiongreater than the unstressed cross-sectional dimension of the coronarysinus to change the shape of the mitral valve annulus. The force applieralso preferably has an axial length substantially less than half thecircumference of the mitral valve annulus.

[0018] The device may be an expandable structure that expands from acollapsed condition to an expanded condition defining a deployedtransverse dimension greater than the unstressed diameter of thecoronary sinus. The device may be a frame structure. The device may beballoon expandable, mechanically expandable, or self-expandable.

[0019] The device may further include a force distributor thatdistributes the applied force along a pericardial wall of the coronarysinus. The force applier may be configured to apply the applied force toa plurality of discrete portions of the atrial wall of the coronarysinus. The surface area of the force distributor is preferablysubstantially greater than the surface area of the force applier.

[0020] The present invention further provides a mitral valve therapydevice configured to be placed in the coronary sinus of a heart adjacentto the mitral valve annulus, the device including a force distributorand a force applier. The force distributor distributes an applied forcealong a pericardial wall of the coronary sinus and the force applierapplies the applied force to at least one discrete portion of a wall ofthe coronary sinus adjacent to the mitral valve annulus to concentratethe applied force on at least one discrete portion of the mitral valveannulus.

[0021] The force applier has a length substantially less than one halfthe mitral valve annulus circumference. The force applier may apply theapplied force to a plurality of discrete portions of the wall of thecoronary sinus adjacent to the mitral valve annulus.

[0022] The force distributor may include an elongated first memberconfigured to substantially continuously contact the pericardial wall ofthe coronary sinus and the force applier may include a second memberextending from the first member at an angle and having an end thatapplies the applied force.

[0023] The second member may be resiliently connected to the firstmember. The first and second members may be integrally formed from asame elongated member which may be formed from a resilient material. Thesecond member extend from the first member intermediate opposed ends ofthe first member.

[0024] The force applier may further include at least one additionalmember extending from the first member intermediate the opposed ends ofthe first member. The at least one additional member may extend from thefirst member substantially parallel to the second member. The first andsecond members may form an integral structure.

[0025] The force distributor may be an elongated frame structure and theforce applier may be at least one columnar frame structure extendingfrom the elongated frame structure. The at least one columnar framestructure is preferably expandable from a collapsed condition to anexpanded columnar condition. The at least one columnar frame structuremay be balloon expandable or self-expandable.

[0026] The elongated frame structure may also be expandable from acollapsed condition to an expanded condition. The elongated framestructure may be balloon expandable or self-expandable.

[0027] The force applier may include a plurality of columnar framestructures. The plurality of columnar frame structures preferably areexpandable from a collapsed condition to an expanded columnar condition.The plurality of columnar frame structures may be balloon expandable orself-expandable.

[0028] The device may be an elongated frame structure. The elongatedframe structure may have a portion of increased transverse dimension toform the force applier. The elongated frame structure may be expandablein transverse dimension and be balloon expandable.

[0029] The device may be an elongated member having outwardly curved endportions that engage the pericardial wall of the coronary sinus to formthe force distributor and an inwardly curved portion between theoutwardly curved end portions to form the force applier.

[0030] The invention further provides a method of treating dilatedcardiomyopathy of a heart including the step of applying a force to adiscrete localized portion of an atrial wall of a coronary sinus toconcentrate the force on a corresponding localized portion of a mitralvalve annulus to change the shape of the mitral valve annulus. Theapplying step may include the step of implanting a force applying devicein the coronary sinus, the device applying the force to the discretelocalized portion of the coronary sinus. The device is preferablyexpandable from a collapsed condition to a deployed condition. Theimplanting step is preferably carried out while the device is in thecollapsed condition, and the device is preferably expanded to thedeployed condition after the device is implanted. The device may beself-expandable, expanded with a balloon, or be mechanically expandable.

[0031] The method may further include the step of distributing theapplied force along a pericardial wall of the coronary sinus. Theapplying step may include the step of applying the force to a pluralityof discrete localized portions of the atrial wall of the coronary sinuswhile the applied force is distributed along the pericardial wall of thecoronary sinus. The applying step may include the step of implanting aforce applying device in the coronary sinus, the device applying theforce to the plurality of discrete localized portions of the coronarysinus. The device is preferably expandable from a collapsed condition toa deployed condition and the implanting step is preferably carried outwhile the device is in the collapsed condition. The device may then beexpanded to the deployed condition after the device is implanted.

BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The features of the present invention which are believed to benovel are set forth with particularity in the appended claims. Theinvention, together with further aspects and advantages thereof, maybest be understood by making reference to the following descriptiontaken in conjunction with the accompanying drawings, and the severalfigures of which like reference numerals identify identical elements,and wherein:

[0033]FIG. 1 is a superior view of a human heart with the atria removed;

[0034]FIG. 2 is a superior view of a human heart similar to FIG. 1illustrating a deployed mitral valve device embodying the presentinvention;

[0035]FIG. 3 is a superior view of a human heart similar to FIG. 1illustrating another deployed mitral valve device embodying the presentinvention;

[0036]FIG. 4 is another superior view of a human heart similar to FIG. 1illustrating a still further mitral valve device embodying the presentinvention;

[0037]FIG. 5 is a further superior view of a human heart similar to thatof FIG. 1 illustrating a still further mitral valve device embodying thepresent invention;

[0038]FIG. 6 is a perspective view of another mitral valve deviceembodying the present invention;

[0039]FIG. 7 is another perspective view of a further mitral valvedevice structured in accordance with the present invention;

[0040]FIG. 8 is another superior view of a human heart similar to FIG. 1illustrating a still another implanted mitral valve device embodying thepresent invention;

[0041]FIG. 9 is a side view of the device of FIG. 8 being expanded by aballoon into a deployed condition in accordance with the presentinvention;

[0042]FIG. 10 is a perspective view of another mitral valve device shownin a collapsed condition in accordance with the present invention;

[0043]FIG. 11 is another perspective view of the device of FIG. 9 shownin an expanded deployed condition in accordance with the presentinvention; and

[0044]FIG. 12 is a perspective view of still another mitral valve deviceembodying the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0045] Referring now to FIG. 1, it is a superior view of a human heart10 with the atria removed to expose the mitral valve 12, the coronarysinus 14, the coronary artery 15, and the circumflex artery 17 of theheart 10 to lend a better understanding of the present invention. Alsogenerally shown in FIG. 1 are the pulmonary valve 22, the aortic valve24, and the tricuspid valve 26 of the heart 10.

[0046] The mitral valve 12 includes an anterior cusp 16, a posteriorcusp 18 and an annulus 20. The annulus encircles the cusps 16 and 18 andmaintains their spacing to provide a complete closure during a leftventricular contraction. As is well known, the coronary sinus 14partially encircles the mitral valve 12 adjacent to the mitral valveannulus 20. As is also known, the coronary sinus is part of the venussystem of the heart and extends along the AV groove between the leftatrium and the left ventricle. This places the coronary sinusessentially within the same plane as the mitral valve annulus making thecoronary sinus available for placement of the mitral valve therapydevice of the present invention therein.

[0047] The circumflex artery 17 branches from the coronary artery 15 andsupplies blood flow to critical tissue of the heart 10. The circumflexartery passes beneath the coronary sinus 14 at a crossover point 19. Aswill be seen hereinafter, the devices of the present invention avoidconstriction of blood flow through the circumflex artery 17 whendeployed in the coronary sinus 14.

[0048]FIG. 2 shows a mitral valve therapy device 30 embodying thepresent invention. As may be noted in FIG. 2, the device 30 has anelongated base or first member 32 having an arched configuration tosubstantially continuously contact the pericardial wall 13 of thecoronary sinus 14. As will be seen hereinafter, the base 32 forms anapplied force distributor that distributes a force applied to the atrialwall 21 of the coronary sinus 14 and the adjacent mitral valve annulus20 that reshapes the mitral valve annulus for terminating mitralregurgitation. To that end, the device includes a second member 34 whichextends from the first member 32 at an angle 36. The second member 34extends from the base 32 intermediate the ends 38 and 40 of the base.The second member contacts the atrial wall 21 of the coronary sinus 14to apply an applied force to a localized discrete portion 23 thereof anda corresponding localized discrete portion 25 of the mitral valveannulus 20. Hence, the applied force as illustrated, reshapes the mitralvalve annulus 20.

[0049] The force applying second member 34 may take a configuration of aloop as shown or other configuration providing an end 42 which willapply the applied force without piercing or otherwise damaging thecoronary sinus 14 or mitral valve annulus. The device 32 is preferablyformed of a resilient biocompatible material. To that end, the device 32may be formed of, for example, Nitinol, a nickel titanium alloy, wellknown in the art. This material, as is well known, is capable of beingpreformed but manipulated to be straight or partially bent while havingsufficient memory to return to its preformed configuration. Stainlesssteel is also among the materials which may be used in forming thedevice 30. The first and second members 32 and 34 may be formed of thesame material as an integral structure or may be formed of differentmaterials.

[0050] As will be noted in FIG. 2, the distal end 38 of the base 32terminates proximally of the crossover point 19 of the circumflex artery17 and coronary sinus 14. Hence, the device 32 avoids adverselyeffecting the blood supply provided by the circumflex artery.

[0051] Referring now to FIG. 3, it illustrates another mitral valvedevice 50 embodying the present invention implanted in the coronarysinus 14 of the heart 10. The device 50 is formed from a singleelongated member of material which may be any one of the materialspreviously referred to. The device 50 includes a pair of outwardlycurved end portions 52 and 54 that substantially continuously engage thepericardial wall 13 of the coronary sinus 14. The end portions 52 and 54thus form the force distributor of the device 50 that distributes anapplied force along the pericardial wall 13 of the coronary sinus 14.The device 50 further includes an inwardly curved portion 56 between theoutwardly curved end portions 52 and 54 to form the force applier. Aswill be noted in FIG. 3, the force applier 56 applies an applied forceto a localized discrete portion 23 of the atrial wall 21 of the coronarysinus 14. This in turn applies the applied force to the correspondinglocalized discrete portion 25 of the mitral valve annulus 20. Theforegoing results in the reshaping of the mitral valve annulus 20 fortreating dilated cardiomyopathy.

[0052] It may also be noted in FIG. 3 that the distal end 58 of thedevice 50 is proximal to the crossover point 19 of the circumflex artery17 and the coronary sinus 14. Hence, in accordance with this embodiment,the blood supply of the circumflex artery is not effected by the device50.

[0053] Referring now to FIG. 4, it shows another mitral valve device 60embodying the present invention implanted and deployed in the coronarysinus 14 of the heart 10. The device 60 takes the form of an expandableframe structure 62 which may be formed from Nitinol, for example. Thedevice 60 may be first implanted in the coronary sinus 14 in a collapsedcondition and then thereafter expanded to a deployed condition asillustrated. The device may be expanded by a balloon as known in theart, for example.

[0054] Alternatively, the device 60 may be self-expanding. Moreparticularly, the frame structure may be formed from Nitinol or othersimilar titanium based elastic material known in the art and heattreated as is known in the art while the device is in its expandeddeployment condition. This sets the device. However, the device may thenbe collapsed and advanced into the coronary sinus with a catheter. Afterreaching a desired location within the coronary sinus, the collapseddevice may be released from the catheter. Upon being released, thedevice will spring or self-expand to its expanded set and deployedcondition.

[0055] When deployed, the device 60 has a transverse cross-sectionaldimension 64 greater than the unstressed cross-sectional dimension 66 ofthe coronary sinus 14. As a result, the device 60, when deployed,applies an applied force to a discrete portion 23 of the atrial wall 21of the coronary sinus 14. This in turn applies the applied force to adiscrete portion 25 of mitral valve annulus 20 to reshape the mitralvalve annulus.

[0056] As will be particularly noted in FIG. 4, and also applicable toall of the embodiments of the present invention disclosed herein, theforce applier has an axial length substantially less than one-half thecircumference of the mitral valve annulus 20. This differs greatly fromprior art devices which attempt to reshape the mitral valve annulus bycircumscribing essentially the entire length of the mitral valve annulusthat lies along the coronary sinus. While such devices may be effective,their generalized mitral valve annulus reshaping is in sharp contrast tothe localized discrete reshaping of the mitral valve annulus provided bythe devices and method of the present invention.

[0057]FIG. 5 shows another mitral valve device 70 embodying the presentinvention implanted in the coronary sinus 14 of the heart 10. The device70 is an elongated frame structure 72. As will be noted in FIG. 5, thedevice 70 has a portion 74 of increased transverse dimension 76. Theportion of increased transverse dimension 76 cause an applied force tobe applied to a discrete portion 23 of the atrial wall of the coronarysinus 14. This in turn causes the applied force to be applied to adiscrete portion 25 of the mitral valve annulus 20 to reshape the mitralvalve annulus 20.

[0058] The frame structure 72 is preferably expandable from a collapsedcondition permitting the device 70 to be implanted to an expandeddeployed condition as illustrated to apply the applied force. The framestructure 72 is preferably self-expanding as previously described or maybe expanded by other means such as by mechanical expansion or balloonexpansion. For self-expansion, the frame structure is preferably formedfrom Nitinol or another titanium based elastic material. For mechanicalor balloon expansion, the frame structure 72 may be formed fromstainless steel, for example.

[0059]FIG. 6 is a perspective view of another mitral valve device 80embodying the present invention. The device has an elongatedsemi-tubular base 82 having cut-out portions 84 to allow bending of thebase 82. Between the cut-out portions 84 are semi-cylindrical surfaces86 arranged to continuously contact the pericardial wall of the coronarysinus when the device 80 is implanted in the coronary sinus todistribute the applied force.

[0060] The device 80 further includes a force applying member 88 whichextends from opposed sidewalls 90 and 92 intermediate the ends of thebase 82. The member 88 has an end 94 for engaging a discrete portion ofthe atrial wall of the coronary sinus to apply the applied force to adiscrete portion of the mitral valve annulus to reshape the mitral valveannulus.

[0061] The device 80 may be formed by laser cutting a Nitinol tube orfrom another suitable material. The member 88 may be set in theillustrated position by heat treating but capable of resiliently bendingin line with the sidewalls 90 and 92 for implanting and thereafter selfexpand to return to the deployed condition shown.

[0062]FIG. 7 is a perspective view of another mitral valve device 100embodying the present invention which is similar to the device 80 ofFIG. 6. The device 100 has an elongated semi-tubular base 102 havingcut-out portions 104 to allow bending of the base 102. Between thecut-out portions 104 are semi-cylindrical surfaces 106 arranged tocontinuously contact the pericardial wall of the coronary sinus when thedevice 100 is implanted in the coronary sinus to distribute the appliedforce.

[0063] The device 100 further includes a pair of force applying members108 and 109 which extend substantially parallel to each other fromopposed sidewalls 110 and 112 intermediate the ends of the base 102. Themembers 108 and 109 each have an end 114 and 116 for engaging the atrialwall of the coronary sinus to apply the applied force to a plurality ofdiscrete portions of the atrial wall of the coronary sinus to in turnapply the applied force to corresponding discrete portions of the mitralvalve annulus to reshape the mitral valve annulus.

[0064] The device 100 may also be formed by laser cutting a Nitinol tubeor from another suitable material. The members 108 and 109 may be set inthe illustrated position by heat treating but capable of resilientlybending in line with the sidewalls 110 and 112 for implanting and tothereafter spring to the deployed condition as shown.

[0065]FIG. 8 shows still another mitral valve device 120 embodying thepresent invention implanted in the coronary sinus 14 of the heart 10.Like the device 100 of FIG. 7, it applies an applied force to aplurality of discrete portions 23 of the atrial wall of the coronarysinus 14 to in turn apply the force to a corresponding plurality ofdiscrete portions 25 of the mitral valve annulus 20 to reshape themitral valve annulus 20.

[0066] The device 120 takes the form of a frame structure 122 having anelongated base 124 that makes substantially continuous contact with thepericardial wall 13 of the coronary sinus 14.

[0067] The base 124 is semi-tubular. Extending from the base 124 areintegral columnar structures 126 and 128. The columnar structures 126and 128 form the force applier to apply the applied force to theplurality of discrete portions of the atrial wall of the coronary sinus.

[0068] The frame structure, like the other frame structures describedherein, is expandable from a collapsed condition to permit implanting ofthe device to an expanded condition, once implanted, as shown. To thatend, the frame structure 122 may be expanded by balloon expansion,mechanical expansion, or self expansion. When deployed as illustrated,the base 124 has a greater surface area than the columnar structures 126and 128 to distribute the applied force along the pericardial wall 13 ofthe coronary sinus 14.

[0069]FIG. 9 shows how the device 120 of FIG. 8 may be expanded with aballoon from its collapsed condition to its expanded condition. Here itmay be seen that a balloon 130 is inserted into the device 120.Thereafter, the balloon 130 is inflated. As the balloon 130 inflates, itforces the frame structure 122 to expand to its expanded condition toform the deployed base 124 and then deployed columnar structures 126 and128.

[0070]FIGS. 10 and 11 show a still further device 140 embodying thepresent invention and which may be mechanically expanded to a deployedcondition. As best seen in FIG. 10, the device 140, when in thecollapsed condition, takes the form of a hollow cylinder 142 havingslits 144 along its axial length. Extending through the hollow cylinder142 is a pull wire 146. The pull wire terminates in an enlarged end 148.

[0071] As best seen in FIG. 11, when the collapsed device is positionedin the coronary sinus for deployment, the pull wire 136 is pulledproximally while the hollow cylinder 142 is held stationary against agrip spring 150. This causes the hollow cylinder to bend along the slits144 like a toggle bolt to form a plurality of blades 152. The bladesthen form a force applier which apply a force to a discrete portion ofthe coronary sinus to reshape the mitral valve annulus.

[0072]FIG. 12 shows a still further device 160 embodying the presentinvention. Here the device is expandable as it takes the form of aballoon 162. The balloon, when inflated to a deployed condition has ahollow core 164 to permit blood flow through the coronary sinus. Bybeing inflated, the device 160 is expanded for applying a force to adiscrete portion of the coronary sinus to reshape the mitral valveannulus.

[0073] The balloon 162 is inflated by a balloon catheter 166 whichcarries the balloon 162. The balloon, when deflated, and the catheter166 are guided into position within the coronary sinus by a guide wire168 upon which the catheter 166 is mounted. When the balloon ispositioned within the coronary sinus as desired, the balloon is inflatedby the introduction of a fluid or gas into an inflation port 170 of theballoon catheter 166 for applying an applied force to a discrete portionof the mitral valve annulus. The device of FIG. 12 is particularly wellsuited for temporary use, for example, to measure the effectiveness of adevice in various positions or of various sizes.

[0074] As may be seen from the foregoing, the present invention providesa mitral valve device and method for reshaping the mitral valve annulusto treat dilated cardiomyopathy. The devices apply an applied force toone or more desirable discrete portions of the atrial wall of thecoronary sinus to reshape the adjacent mitral valve annulus in alocalized, as opposed to a generalized, manner. Further, all of theembodiments disclosed herein avoid the crossover point of the circumflexartery and the coronary sinus.

[0075] While particular embodiments of the present invention have beenshown and described, modifications may be made, and it is thereforeintended in the appended claims to cover all such changes andmodifications which fall within the true spirit and scope of theinvention.

1.-65. (Canceled)
 66. A device that effects the condition of a mitralvalve annulus of a heart comprising an elongated member dimensioned tobe placed in the coronary sinus of the heart adjacent the mitral valveannulus, the elongated member having a relatively low resistance toflexure in a first direction and a relatively high resistance to flexurein a second direction, wherein the first and second directions lie inthe same plane.
 67. The device of claim 66 wherein the elongated memberincludes a first longitudinal side facing the first direction and afirst plurality of notches formed in the first longitudinal side toprovide the elongated member with the relatively low resistance toflexure in the first direction.
 68. The device of claim 67 wherein theelongated member includes a second longitudinal side facing the seconddirection and a second plurality of notches formed in the secondlongitudinal side to render the elongated member stable when flexed inthe second direction.
 69. The device of claim 66 wherein the elongatedmember is bent to conform to the shape of the coronary sinus when in afirst orientation.
 70. The device of claim 69 wherein the elongatedmember has a first radius of curvature when in the first orientation, asecond radius of curvature when in a second orientation, and wherein thefirst radius of curvature is less than the second radius of curvature.71. A device that effects the condition of a mitral valve annulus of aheart comprising an elongated member dimensioned to be placed in thecoronary sinus of the heart adjacent the mitral valve annulus, theelongated member having a relatively low resistance to flexure in afirst direction and a relatively high resistance to flexure in a seconddirection, wherein the elongated member includes a first longitudinalside facing the first direction and a first plurality of notches formedin the first longitudinal side to provide the elongated member with therelatively low resistance to flexure in the first direction, and whereinthe elongated member includes a second longitudinal side facing thesecond direction and a second plurality of notches formed in the secondlongitudinal side to render the elongated member stable when flexed inthe second direction.
 72. The device of claim 71 wherein the firstplurality of notches are larger than the second plurality of notches.73. The device of claim 72 wherein the first and second directions liein the same plane.
 74. The device of claim 71 wherein the first andsecond longitudinal sides are opposite each other.
 75. The device ofclaim 74 wherein the first and second directions lie in the same plane.76. The device of claim 71 wherein the elongated member is bent toconform to the shape of the coronary sinus when in a first orientation.